Carl Zeiss Surgical (Thornwood, New York) said it has reached another milestone in its focus on providing service. In a self-audit process, Carl Zeiss Surgical hired an outside firm to evaluate the satisfaction level of their customers, and found what it called "impressive results."
"We wanted to accurately gauge the satisfaction level of our customers, and felt that hiring an external evaluator would be the only way to gain a truly unbiased perspective," said Carl O'Connell, president of Carl Zeiss, Surgical. He added, "We're thrilled with the results, but it's important not to let complacency set in. Our management team is currently working on strategies to ensure we maintain and exceed these results in future months."
FDA OKs protocol changes for Corautus trial
Corautus Genetics (Atlanta) said that the FDA has approved several amendments to the clinical trial protocol for GENASIS, relating to patient enrollment requirements for the trial. GENASIS is Corautus' Phase IIb clinical trial to evaluate the safety and efficacy of Vascular Endothelial Growth Factor-2 (VEGF-2) for the treatment of patients with refractory angina.
GENASIS is a randomized, double-blinded, dose-ranging and placebo-controlled Phase IIb clinical trial, which will enroll 404 patients with Class III or IV angina that are not suitable candidates for traditional revascularization procedures. The GENASIS trial will be conducted in about 25 cardiac medical centers throughout the U.S.
In the GENASIS trial, defined doses of VEGF-2 in the form of "naked" plasmid DNA, a non-viral delivery vector, are delivered to diseased heart muscle tissue via the Boston Scientific (Natick, Massachusetts) Stiletto endocardial direct injection catheter system. The injection procedure is performed by a cardiologist in a standard cardiac laboratory.